Geometric mean ratios of LYN-005 versus immediate-release risperidone met predetermined criteria
By Elana Gotkine HealthDay Reporter
WEDNESDAY, June 18, 2025 (HealthDay News) — For patients with schizophrenia, weekly LYN-005 provides sustained release of risperidone at therapeutic concentrations, according to a study published online June 11 in The Lancet Psychiatry.
Leslie Citrome, M.D., from the New York Medical College School of Medicine in Valhalla, and colleagues conducted an open-label, nonrandomized, phase 3 trial involving clinically stable participants with schizophrenia or schizoaffective disorder. Participants received five doses of long-acting oral weekly LYN-005 (15 mg or 45 mg), with a supplemental half dose of daily immediate-release risperidone during week 1, after a seven-day run-in period with immediate-release risperidone. Pharmacokinetic parameters of LYN-005 (minimum concentration [Cmin] at weeks 1 and 5, and maximum concentration [Cmax] and average concentration [Cavg] at week 5) were compared to those of immediate-release risperidone on the last day of the run-in period.
Eighty-three patients were enrolled in the study, 47 of whom completed the study. The researchers found that sustained release of the active moiety was observed across all doses of LYN-005 in the pharmacokinetic analysis. The geometric mean ratios of LYN-005 versus immediate-release risperidone met the predetermined criteria and were 1.02 for Cmin at week 1 and 1.04, 0.84, and 1.03 for Cmin, Cmax, and Cavg, respectively, at week 5. Gastrointestinal treatment-emergent adverse events were most common among individuals taking LYN-005 (66 percent); there was one serious treatment-emergent adverse event.
“Having the option to take medication by mouth once a week represents an important option that can assist with adherence for the many patients who would prefer oral medications versus injectable formulations,” Citrome said in a statement.
Several authors disclosed ties to biopharmaceutical companies, including Lyndra Pharmaceuticals, which is developing LYN-005 and funded the study.
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